FDA Approves Sonidegib for Locally Advanced Basal Cell Carcinoma

The FDA has approved sonidegib (Odomzo) for the treatment of basal cell carcinoma that has recurred following surgery or radiotherapy.

Sonidegib works by inhibiting the Hedgehog signaling pathway, which ultimately inhibits or reduced cancerous lesion growth. It is to be taken at a dose of 200 mg once daily.

“Our increasing understanding of molecular pathways involved in cancer has led to approvals of many oncology drugs in difficult-to-treat diseases for which few therapeutic options previously existed,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

“Thanks to a better understanding of the Hedgehog pathway, the FDA has now approved two drugs for the treatment of basal cell carcinoma just in the last 3 years.”

Clinicians should be aware that sonidegib carries a Boxed Warning alerting health care professionals that the drug may cause severe embryo-fetal toxicity when administered to a pregnant women. Clinicians should verify the pregnancy status of patients prescribed sonidegib and both partners should be advised to use effective contraception.

FDA approval is based on a multicenter, double-blind study that evaluated sonidegib 200 mg daily and 800 mg daily in patients with locally advanced basal cell carcinoma. Results showed similar response rates between the two treatment arms, but adverse events were more common at the higher dose.

Odomzo is the second Hedgehog pathway inhibitor to be approved by the FDA. Erivedge (vidmodegib) was initially approved in 2012 for the treatment of patients with locally advanced or metastatic basal cell carcinoma.

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